Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Last updated: April 28, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Migraine (Adult)

Oral Facial Pain

Treatment

Rimegepant (PF-07899801)

Rimegepant / BHV3000

Clinical Study ID

NCT04743141
BHV3000-312
C4951003
2020-003761-18
BHV3000-312
2024-512744-32-00
  • Ages 6-17
  • All Genders

Study Summary

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to < 18 years of age).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. History of migraine (with or without aura) for ≥ 6 months before Screening.

  2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior toscreening.

  3. 1 or more migraine days requiring treatment during the Observation Phase.

  4. Prophylactic migraine medication is permitted if the dose has been stable for atleast 12 weeks prior to the Screening Visit.

  5. Ability to distinguish between migraine and other types of headaches.

  6. Weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age musthave a body weight of >25kg.

  7. Adequate venous access for blood sampling.

  8. Male and female participants 6 to < 18 years of age (participants must not reachtheir 18th birthday on or before the Baseline visit).

Exclusion

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.

  2. Confounding and clinically significant pain syndrome.

  3. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6months prior to the Screening Visit (lifetime history of psychosis and/or mania areexcluded).

  4. History of suicidal behavior or at risk of self-harm/harm to others.

  5. History of major psychiatric disorder.

  6. Current diagnosis or history of substance abuse

  7. Reported current use of or tested positive at Screening for drugs of abuse.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Rimegepant (PF-07899801)
Phase: 3
Study Start date:
April 28, 2021
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp. K.

    Poznań, Wielkopolska 61-731
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci

    Karkow, 31-503
    Poland

    Site Not Available

  • NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapis"

    Katowice, 40-123
    Poland

    Site Not Available

  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski

    Katowice, 40-123
    Poland

    Terminated

  • Centrum Medyczne Plejady

    Krakow, 30-363
    Poland

    Active - Recruiting

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci

    Krakow, 31-503
    Poland

    Active - Recruiting

  • Centrum Medyczne Plejady

    Kraków, 30-363
    Poland

    Site Not Available

  • Clinical Research Center Sp. z o.o.

    Poznań, 60-848
    Poland

    Active - Recruiting

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k

    Poznań, 61-731
    Poland

    Active - Recruiting

  • Euromedis Sp. z o. o.

    Szczecin, 70-111
    Poland

    Site Not Available

  • Euromedis Sp. z o.o. Osrodek B

    Szczecin,, 70-111,
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Pracownia Badan Klinicznych SALUS

    Wroclaw, 52-210
    Poland

    Active - Recruiting

  • Centrum Medyczne Oporow

    Wrocław, 52-416
    Poland

    Site Not Available

  • Centre Atencio Primaria (CAP) Balenya

    Balenya, Barcelona 08550
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • CAP Balenyà

    Barcelona, 08550
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitari Vall dHebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Instituto de Investigaciones del Sueno

    Madrid, 28036
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio (HUVR)

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio HUVR

    Seville, 41013
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Physicians Research Group

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Perseverance Research Center, LLC

    Scottsdale, Arizona 85253
    United States

    Active - Recruiting

  • Physicians Research Group

    Tempe, Arizona 85284
    United States

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  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Active - Recruiting

  • Velocity Clinical Research - Banning

    Banning, California 99202
    United States

    Site Not Available

  • Velocity Clinical Research- Banning

    Banning, California 92220
    United States

    Site Not Available

  • The Neuron Clinic

    Chula Vista, California 91910
    United States

    Site Not Available

  • ProScience Research Group

    Culver City, California 90230
    United States

    Active - Recruiting

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Active - Recruiting

  • Altman Clinical and Translational Research Institute-IDS

    La Jolla, California 92037
    United States

    Active - Recruiting

  • University of California San Diego, Altman Clinical and Translational Research Institute Clinic

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Sunwise Clinical Research

    Lafayette, California 94549
    United States

    Active - Recruiting

  • Memorialcare Miller Children's & Women's Hospital Long Beach

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Miller Children's & Women's Hospital Long Beach

    Long Beach, California 90806
    United States

    Site Not Available

  • Children's Hospital Los Angeles - Children's Hospital Los Angeles Dept of Pharmacy

    Los Angeles, California 90027
    United States

    Site Not Available

  • Children's Hospital Los Angeles, Division of Neurology

    Los Angeles, California 90027
    United States

    Site Not Available

  • National Research Institute

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Velocity Clinical Research - North Hollywood

    North Hollywood, California 91606
    United States

    Active - Recruiting

  • The Neurology Group

    Pomona, California 91767
    United States

    Active - Recruiting

  • UC Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California, Davis Clinical and Translational Science Center Clinical Research Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California, Davis Midtown Clinic

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Velocity Clinical Research- Banning

    San Bernardino, California 92408
    United States

    Active - Recruiting

  • Rady Children's Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Pacific Clinical Research Management Group LLC

    Upland, California 91786
    United States

    Active - Recruiting

  • Pacific Clinical Research Management Group, LLC

    Upland, California 91786
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Children's Hospital Colorado Investigational Drug Services

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Children's Hospital Colorado- Investigational Drug Services

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Boeson Research - Grand Junction, CO

    Grand Junction, Colorado 81505
    United States

    Active - Recruiting

  • Boeson Research GJT

    Grand Junction, Colorado 81501
    United States

    Terminated

  • Dinosaur Pediatrics

    Grand Junction, Colorado 81501
    United States

    Terminated

  • CT Clinical Research

    Cromwell, Connecticut 06416
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Ki Health Partners, LLC, dba New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • Ki Health Partners, LLc, dba New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • Children's National Hospital

    Washington, District of Columbia 20003
    United States

    Site Not Available

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida 33157
    United States

    Site Not Available

  • Sarkis Clinical Trials

    Gainesville, Florida 32607
    United States

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  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida 32055
    United States

    Site Not Available

  • AppleMed Research Group, LLC

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Brainstorm Research

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Medical Research Center of Miami II, Inc

    Miami, Florida 33134
    United States

    Site Not Available

  • South Florida Research Phase I-IV, Inc

    Miami Springs, Florida 33166
    United States

    Active - Recruiting

  • Advanced Research for Health Improvement LLC

    Naples, Florida 34102
    United States

    Site Not Available

  • Coastal Clinical Research Specialists

    Orange Park, Florida 32073
    United States

    Active - Recruiting

  • Clinical Associates of Orlando, LLC

    Orlando, Florida 32819
    United States

    Site Not Available

  • Orlando Health Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice

    Orlando, Florida 32806
    United States

    Site Not Available

  • AppleMed Research Group LLC

    South Miami, Florida 33155
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Childrens Healthcare of Atlanta

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Rare Disease Research LLC

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Pivotal Clinical Research & Associates, LLC

    Brunswick, Georgia 31520
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Chicago Headache Center & Research Institute

    Chicago, Illinois 60657
    United States

    Active - Recruiting

  • Children's Clinical Research Center at Riley Hospital for Children at IU Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Riley Hospital for Children at IU Health

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Physicians Research Group

    Noblesville, Indiana 46060
    United States

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  • Physicians Research Group (Administrative Office Location)

    Noblesville, Indiana 46060
    United States

    Active - Recruiting

  • Options Research Group, LLC

    Westfield, Indiana 46074
    United States

    Active - Recruiting

  • UnityPoint Clinic

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Integrated Clinical Trial Services

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • College Park Family Care Center Physician Service Group - Neruology Research Department

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • University of Kentucky Hospital

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Terminated

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • MedVadis Research

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Corewell Health, Helen DeVos Children's Hospital

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Outpatient Pediatric Neurology Clinic

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Wellnow Urgent Care and Research

    Kalamazoo, Michigan 49048
    United States

    Terminated

  • Beaumont Hospital, Royal Oak Campus

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Sharlin Health Neuroscience Research Center

    Ozark, Missouri 65721
    United States

    Active - Recruiting

  • Clinvest Research, LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Boeson Research

    Great Falls, Montana 59405
    United States

    Active - Recruiting

  • Northwest Physicians

    Great Falls, Montana 59405
    United States

    Active - Recruiting

  • Boeson Research (HLN)

    Helena, Montana 59601
    United States

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  • Boeson Research HLN

    Helena, Montana 59601
    United States

    Site Not Available

  • Boeson Research,LLC

    Kalispell, Montana 59901
    United States

    Active - Recruiting

  • Boeson Research

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • Alivation Research, LLC

    Lincoln, Nebraska 68526
    United States

    Terminated

  • HMH Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Dent Neurosciences Research Center

    Amherst, New York 14226
    United States

    Active - Recruiting

  • True North Neurology

    Commack, New York 11725
    United States

    Site Not Available

  • Columbia University Medical Center Research Pharmacy

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Pediatric Neuromuscular Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit

    New York, New York 10032
    United States

    Active - Recruiting

  • Mount Sinai Hospital - Pharmacy Department

    New York, New York 10029
    United States

    Site Not Available

  • New York Neurology Associates

    New York, New York 10003
    United States

    Active - Recruiting

  • The Neurological Institute of New York

    New York, New York 10032
    United States

    Active - Recruiting

  • North Suffolk Neurology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • Mecklenburg Neurology Group

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Headache Wellness Center

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • Headache Wellness Center, PC

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Drug Delivery-Cincinnati Children's IDS Denise Lagory

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • WellNow Urgent Care and Research

    Cincinnati, Ohio 45215
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Wellnow Urgent Care and Research

    Columbus, Ohio 43228
    United States

    Site Not Available

  • Wellnow Urgent Care and Research

    Dayton, Ohio 45424
    United States

    Site Not Available

  • IPS Research Company

    Oklahoma City, Oklahoma 73106
    United States

    Site Not Available

  • Velocity Clinical Research, Grants Pass

    Grants Pass, Oregon 97527
    United States

    Active - Recruiting

  • Providence Brain & Spine Institute-research coordinator's office

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Providence Brain and Spine Institute

    Portland, Oregon 97225
    United States

    Site Not Available

  • Providence Health & Services Investigational Drug Services Westside

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Velocity Clinical Research-Providence

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Tribe Clinical Research LLC

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

  • Velocity Clinical Research- Greenville

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Premier Neurology

    Greer, South Carolina 29650
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Novaceut Clinical Research

    Clarksville, Tennessee 37043
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • Le Bonheur Childrens Hospital - Childrens Foundation Research Institute

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • Le Bonheur Childrens Hospital - Outpatient Building

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • Access Clinical Trials, Inc.

    Nashville, Tennessee 37203
    United States

    Terminated

  • Child Neurology Consultants of Austin - Central Austin

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Child Neurology Consultants of Austin - Central Austin Office

    Austin, Texas 78757
    United States

    Site Not Available

  • Child Neurology Consultants of Austin - South Austin

    Austin, Texas 78749
    United States

    Active - Recruiting

  • Dell Children's Medical Center

    Austin, Texas 78723
    United States

    Active - Recruiting

  • Houston Clinical Trials, LLC

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Cedar Health Research

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • ANRC Research

    El Paso, Texas 79912
    United States

    Active - Recruiting

  • North Texas Institute of Neurology and Headache

    Frisco, Texas 75034
    United States

    Site Not Available

  • Houston Clinical Research,LLC.

    Houston, Texas 77081
    United States

    Terminated

  • NeuroCare Plus

    Houston, Texas 77094
    United States

    Active - Recruiting

  • Pain and Headache Centers of Texas

    Houston, Texas 77054
    United States

    Active - Recruiting

  • SCLA Management

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Trio Clinical Trials, LLC.

    Houston, Texas 77008
    United States

    Site Not Available

  • AIM Trials, LLC

    Plano, Texas 75093
    United States

    Active - Recruiting

  • JBR Clinical Research

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Wasatch Clinical Research , LLC(Administrative Location)

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology

    Norfolk, Virginia 23510
    United States

    Active - Recruiting

  • National Clinical Research, Inc.

    Richmond, Virginia 23294
    United States

    Terminated

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Seattle Children's Hospital Investigational Drug Services

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • University Hospital

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • Marshfield Clinic-Marshfield Center

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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